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SUbstition of PERioperative Albumin Deficiency Disorders (SUPERADD)

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ClinicalTrials.gov Identifier: NCT03167645
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

Brief Summary:
Aim of this study is to reduce postoperative complications (assessed by POMS-Score and graded by Clavien-Dindo-Score) by substitution of perioperative hypoalbuminaemia in high-risk patients or patients undergoing high risk surgery.

Condition or disease Intervention/treatment Phase
Hypoalbuminemia Drug: Human albumin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Perioperative Substitution of Albumin Deficiency Reduce Postoperative Complications?
Actual Study Start Date : June 19, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Arm Intervention/treatment
Experimental: Human albumin
Substitution of human albumin until serum albumin >30g/l; dosage: (30 g/l - serum albumin [g/l] ) x 0,04 l/kg x body weight [kg] x 2
Drug: Human albumin
Substitution according to pre-specified dosage
Other Name: Human-Albumin 20 % Behring, salzarm

No Intervention: Control
Standard clinical care



Primary Outcome Measures :
  1. Postoperative complications assessed with POMS- and graded with Clavien-Dindo-Score [ Time Frame: 15 days ]
    Postoperative complications will be detected using the POMS score. The severity of the complications will be graded with the Clavien-Dindo-Score. A complication will be regarded as clinical relevant when it is graded Clavien-Dindo-Score 2 or higher on at least one of the four days examined.


Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: until discharge from hospital, up to 6 month ]
  2. Length of stay in postoperative anaesthesia care unit [ Time Frame: until discharge from postoperative anaesthesia care unit, up to 24 hours ]
  3. Length of stay in intensive care unit [ Time Frame: until discharge from intensive care unit, up to 1 month ]
  4. Long term mortality (6 month) [ Time Frame: 6 month ]
  5. Short term mortality (hospital mortality) [ Time Frame: until discharge from hospital, up to 6 month ]
  6. Acute kidney injury [ Time Frame: until discharge from hospital, up to 6 month ]
    Incidence according to AKIN score (at least AKIN 1)

  7. Quality of Recovery 9 Score [ Time Frame: 6 month after surgery ]
    Assessed preoperatively and on day 1 and 3 an 6 month after surgery

  8. Amount of volume infused [ Time Frame: until discharge from postoperative anaesthesia care unit, up to 24 hours ]
    Amount of infusion of ringer's acetate and gelafundin

  9. Dosage of catecholamines [ Time Frame: until discharge from postoperative anaesthesia care unit, up to 24 hours ]
    Intra- and postoperative dosage of catecholamines

  10. Number of red packed cells transfused [ Time Frame: until discharge from postoperative anaesthesia care unit, up to 24 hours ]
  11. Number of platelet concentrates transfused [ Time Frame: until discharge from postoperative anaesthesia care unit, up to 24 hours ]
  12. Amount of coagulation factors infused [ Time Frame: until discharge from postoperative anaesthesia care unit, up to 24 hours ]
    Amount of PPSB and fibrinogen

  13. Intra- and postoperative Hypotension [ Time Frame: until discharge from postoperative anaesthesia care unit, up to 24 hours ]
    Decrease of more than 30% compared to value before induction

  14. Incidence of pulmonal venous congestion [ Time Frame: until discharge from postoperative anaesthesia care unit, up to 24 hours ]
    Incidence of pulmonal venous congestion assessed using chest x-ray

  15. Therapy with diuretics [ Time Frame: until discharge from hospital, up to 6 month ]
    New onset or extension of diuretic treatment

  16. Efficacy of albumin treatment [ Time Frame: until discharge from hospital, up to 6 month ]
    Efficacy of albumin treatment in order to increase serum albumin and colloid osmotic pressure



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age: 18 years or older
  • written informed consent
  • ASA state 3 and 4 OR
  • elective high risk surgery (open aortic surgery, open leg revascularization, thrombectomy, oesophagectomy, pancreatic surgery, cystectomy, liver surgery, change of knee- or hip-prothesis, amputation)

Exclusion Criteria:

  • emergency surgery
  • severe liver cirrhosis (child pugh C)
  • need for dialysis
  • patients already included in SUPERADD
  • patients with a legal representative
  • contraindications for human albumin: hypersensitivity for human albumin or any substance included in the preparation
  • pregnancy
  • breastfeeding women
  • ASA state 5
  • BMI > 35 kg/m2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167645


Contacts
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Contact: Manfred Blobner, MD +498941404291 m.blobner@tum.de
Contact: Stefan Schaller, MD +498941404291 stefan.schaller@tum.de

Locations
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Germany
Klinikum rechts der Isar Dept. of Anesthesiology Recruiting
Munich, Germany, 81675
Contact: Manfred Blobner, MD    +498941404291    m.blobner@tum.de   
Contact: Stefan Schaller, MD    +498941404291    stefan.schaller@tum.de   
Principal Investigator: Manfred Blobner, MD         
Sub-Investigator: Bettina Jungwirth, MD         
Sub-Investigator: Stefan Schaller, MD         
Sub-Investigator: Sebastian Schmid, MD         
Sub-Investigator: Kristina Eggert, MD         
Sub-Investigator: Catherina Bubb, MD         
Sponsors and Collaborators
Technische Universität München
Investigators
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Principal Investigator: Manfred Blobner, MD Klinikum rechts der Isar, Technical University Munich, Dept. of Anesthesiology

Publications:
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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT03167645     History of Changes
Other Study ID Numbers: SUPERADD
2016-001313-24 ( EudraCT Number )
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypoalbuminemia
Hypoproteinemia
Blood Protein Disorders
Hematologic Diseases